Good day, and welcome to the 2026 Annual Meeting of Stockholders of Anixa Biosciences. I would now like to turn the conference over to Dr. Amit Kumar, Chief Executive Officer and Chairman of the Board of Directors of the company. Please go ahead.
Thank you, Drew. On behalf of the board, our officers, and employees, I would like to welcome everyone to the 2026 Annual Meeting of Stockholders of Anixa Biosciences, which is being held via live webcast. I'm Dr. Amit Kumar. I'm the Chief Executive Officer and Chairman of the Board of Directors of the company. I will act as the chair of this meeting. Here with me today is Mike Catelani, our President, Chief Operating Officer, and Chief Financial Officer, and Secretary of the company, who will act as Secretary of the meeting. Also present today are the members of our Board of Directors, Lew Titterton, Dr. Arnold Baskies, and Emily Gottschalk, as well as Dr. Pamela Garzone, our Chief Development Officer, and Shereen Abushaban, our Office Manager.
Matt Bernstein, our counsel at Ellenoff Grossman & Schole LLP, and Trish Hudson, our representative of Broadridge Financial Solutions, who has been duly appointed as Inspector of Election, are also in attendance. We are pleased to once again conduct our annual meeting virtually via the internet. Virtual shareholder meetings allow for improved access and increased attendance and make it easier for our shareholders and other interested parties to attend. I would now like to call upon Mike Catelani to conduct the business of today's meeting.
Thanks, Amit. Today's meeting will consist of two parts. The first part will be to conduct the business of the annual meeting of stockholders, and the second will be to provide a report on the company. The agenda for the business part of today's meeting will be, first, to address administrative matters and, second, to vote upon the matters being presented for action. We will not be taking questions during the business part of the meeting. After the business part of the meeting is concluded, Dr. Kumar will make a report on the company's affairs, and thereafter, we will have a question-and-answer period. Shareholders of Anixa, as well as any other attendees of the meeting, may submit questions at that time. Please follow the prompts at the bottom of your screen to submit questions at the appropriate time.
Please note that various remarks that company personnel may make about future expectations, plans, and prospects for the company constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is on file with the SEC, and other filings on Form 10-Q and Form 8-K that we make with the SEC. In addition, these forward-looking statements represent the company's expectations only as of today. While the company may elect to update these forward-looking statements, it specifically disclaims any obligation to do so, except as may be required by law.
Any forward-looking statements should not be relied upon as representing the company's estimates or views as of any date subsequent to today. Trish Hudson, a representative of Broadridge Financial Solutions, has been duly appointed as Inspector of Election for today's meeting. Prior to the meeting, Ms. Hudson provided her executed oath of office, whereby she has been sworn to faithfully perform the duties of Inspector of Election with strict impartiality according to the best of her ability. The record date for determining the holders of common stock entitled to notice of and to vote at this meeting was January 13th, 2026. The Inspector of Election has a list of stockholders as of the close of business on the record date, and I direct that this list be filed with the records of the company.
The Inspector of Election also holds an affidavit of Broadridge Financial Solutions attesting that the Notice of Internet Availability of Proxy Materials, 2025 Annual Report, Notice of Annual Meeting of Stockholders, January 28, 2026 proxy statement, and form of proxy were mailed or otherwise delivered commencing on or about January 28, 2026 to each stockholder of record at the close of business on the record date. I direct that the affidavit of mailing, along with the Notice of Annual Meeting and the proxy materials dated January 28, 2026 be annexed to the minutes of this meeting. On the record date, there were 33,379,505 shares of common stock issued, outstanding, and entitled to vote at this meeting. Each share of common stock is entitled to one vote.
For a quorum to be present, the majority of the shares entitled to vote must be present at the meeting. Prior to the meeting, the Inspector of Elections submitted a report of the number of shares of common stock present or represented by proxy at this meeting. Pursuant to the report of the Inspector of Election, there are represented at this meeting, either in person or by proxy, approximately 20,804,434 shares of common stock of the company, constituting 62% of the company's outstanding shares of common stock entitled to vote at this meeting. Therefore, there is a quorum present at this meeting for the transaction of business. All stockholders of record on January 13th, 2026 are eligible to vote either by proxy or virtually at this meeting.
If you have already submitted a proxy to the company and do not wish to change your vote, you do not have to vote again. However, if you have not submitted a proxy or you desire to change your vote, you may vote by following the voting prompts on the bottom of your screen. We will now proceed with the matters to be voted upon at the meeting. The polls are now open. If you wish to vote during the meeting or wish to change your vote, please follow the voting prompts on your screen. The polls will remain open until immediately after the matters to be presented at the meeting have been submitted. The first item of business to come before this meeting is the election of directors for the coming year.
A board of directors of four members is to be elected to serve until the next annual meeting of stockholders or until their successors shall be elected and qualified. The following persons have been nominated to serve as directors: Dr. Amit Kumar, Dr. Arnold Baskies, Ms. Emily Gottschalk, and Mr. Lewis Titterton. In my capacity as a stockholder, I hereby move that the foregoing persons be nominated as directors. Would a stockholder second the nominations, and also please state their name.
This is Amit Kumar, and as a stockholder of the company, I second the nominations.
Since no further nominations can be made under the company's bylaws, the nominations for director are closed. The next item of business to come before the meeting is to approve, on a non-binding advisory basis, the compensation of the company's executive officers. In my capacity as a stockholder, I hereby move that the foregoing motion proceed. Would a stockholder second the motion?
This is Amit Kumar, and I second the motion.
The next item of business is to ratify the appointment by the Board of Directors of the company of the firm of Haskell & White LLP as auditors for the company for fiscal year 2026. In my capacity as a stockholder, I hereby move that the foregoing motion proceed. Would a stockholder second the motion?
This is Amit Kumar, and I second the motion.
All matters to be voted on at this meeting have now been presented. If you have not already voted or you would like to change your vote, please do so now by following the voting prompts on the bottom of your screen. A plurality of the votes cast at this meeting is required to elect directors. The affirmative vote of a majority of the votes cast at this meeting is required to approve, on a non-binding advisory basis, the compensation of the company's executive officers and to ratify the appointment of the company's auditors. At this time, everyone should have completed voting. This concludes the formal business items on the agenda for this annual meeting. The polls are now closed. I hereby present the report of the Inspector of Election duly subscribed by her, giving the preliminary results of the voting.
First, for the election of directors, each of the director nominees has received a plurality of the votes cast, and therefore, each of the director nominees is elected as a director. Second, a majority of the votes cast at this meeting approved, on a non-binding advisory basis, the compensation of the company's executive officers. Therefore, the compensation of the company's executive officers has been approved. Third, a majority of the votes cast at this meeting ratified the appointment of the company's auditors. I shall file the report of the Inspector of Election in the minute book of the company immediately following the minutes of this meeting. As there is no further business to come before this meeting, I would now like to adjourn the formal business part of this meeting.
Dr. Kumar will then present a report on the business of the company and will answer appropriate questions from the stockholders. In my capacity as a stockholder, I hereby move that the meeting be adjourned. Do I hear a second to adjourn the formal part of this meeting?
This is Amit Kumar, and I second the motion.
I declare the formal part of this meeting adjourned. Amit, I would now like to turn the meeting over to you to report on the company.
Thank you, Mike. Let me begin by providing a little bit of background on Anixa. Let's go to the next slide. This is our forward-looking statement. Go on to the next slide. I will talk a little bit about the strategy of the company because it is unique relative to other biotech companies, and an understanding of the strategy will provide better context of our programs and our plans going forward. I will then update on the current projects, primarily focusing on our clinical projects, the projects that are in human clinical trials, and talk about the goals for 2026, and then we'll begin the Q&A session. Let's go on to the next slide. From a strategic standpoint, we are very unique relative to other biotech companies.
The primary goal for our company is to maintain a low cash burn that enables us to dilute shareholders a lot less than traditional biotech companies, obviously resulting, you know, because of the low capital requirements. In addition, we are able to maintain a clean capital structure. Many companies, as you may know in the biotech sector especially, as well as other sectors, have had to do financing deals to fund their operations, requiring overhangs like warrants and preferred stock situations that take a lot of potential upside value away from current common shareholders. We've been able to avoid all of that. As you can see on the right-hand side, we have only common stock outstanding, no preferred stock and no warrants.
Our strategy is focused on utilizing partnerships to conduct our research and development. Most biotech companies will build expensive laboratories and hire a very expensive headcount, physicians, engineers, scientists and so forth to conduct their research and development. We've been able to avoid all of that and maintain a very low cash burn. In fact, our headcount currently is a total of four. Until about two or three years ago when we added Dr. Pam Garzone to help us on the clinical work that we're doing, our headcount was three. In addition, this partnership-based R&D program enables us to diversify our product portfolio.
As you'll see in a moment, our product portfolio, the two clinical products that I'll talk about are in the area of immunotherapy, but utilize very different technologies. We're able to do that because we haven't built infrastructure, headcount, laboratory, et cetera, that is focused on one type of technology. If we had done that, then we would always be required to develop that type of technology for all of our portfolio of products. In addition, our goal long term is to establish partnerships for commercialization of our products. This, again, enables us to conserve cash while we advance commercialization. We, as a small company, do not have the capacity to build expensive and large manufacturing facilities or extensive distribution networks.
To do that would take a tremendous amount of time and require us to raise a tremendous amount of capital. Our goal is to not do that, especially since larger pharmaceutical companies have all of that infrastructure in place already. In addition, this approach enables us to monetize our programs earlier than having to wait until our programs are approved by the regulatory agencies, the FDA and other international regulatory agencies. On the right-hand side, as you can see, our latest results as of the end of the quarter ending January 21, 2026. We have $14 million of cash on the balance sheet, which is over two years of cash at the burn rate that we anticipate going forward.
As I noted earlier, we have 33 million—roughly 33 million shares of common stock outstanding, no debt, and no warrants, or preferred stock. Next slide. This is a graph of annual cash burn over the seven years since this current management, including myself, have been running this company. I should say about seven years. Eight years. If you look at the vertical red line, to the left of that red line is preclinical work. At that time, all of our work was in the laboratory and no human testing. We were burning roughly $5 million or less, with a slight anomaly in the COVID year, 2020. Since we began clinical work, our burn has only increased very modestly because of the way we have run this company.
Typically, if you looked at a graph of this type of burn for typical biotech companies, you would see even higher burn rates on the preclinical side and then dramatically higher burn rates on the clinical side. Our fiscal discipline has enabled us to maintain a very, very modest cash burn. Next slide. This is our portfolio of products. The two products that I'll focus on today are the two that are in clinical trials, our CAR T therapeutic targeting recurrent ovarian cancer patients and our breast cancer vaccine. On the right-hand portion of this slide, you'll see the partners that are working with us on each of those two programs.
The additional products below two in the clinical trials are in preclinical stages, some being funded by outside non-dilutive capital and some at the early discovery stage. Next slide. Let me begin with our CAR T program in ovarian cancer. Go on to the next slide. A little bit of background. As many of you know, CAR T has demonstrated success in certain liquid tumors, but no approvals in solid tumors. Our unique CAR T is designed for a solid tumor, specifically ovarian cancer, and it utilizes three unique attributes. First, we've identified a target that is unique, a target protein that is unique to the type of organ that we are trying to attack, which is, in this case, the ovaries.
No other CAR T therapy that has been in clinical trials targets a unique protein. In all other cases that I'm aware of, the target has always been perhaps overexpressed on the cancer that one is trying to attack, but also expressed on multiple healthy cells and organs. Our situation is very unique. It's only targeting the ovaries, which is the indication for this therapy. In addition, our approach utilizes what we believe is gonna be an anti-angiogenic effect. This enables a dual mechanism of action where our CAR T cells are not only attacking the ovarian cells directly but also disrupting the vasculature or the blood vessels within the tumors that we are targeting. The third unique attribute is that we're delivering our engineered T cells directly into the peritoneum.
Ovarian cancer is one of those unique cancers that is generally localized within the peritoneal cavity, which is a cavity in all of our abdomen that contain, in women, the ovaries as well as other organs. By delivering it to the peritoneum, we're able to avoid a lot of the side effects that occur when CAR T cells are delivered through the vein, intravenous delivery. As I noted, this trial targets recurrent ovarian cancer patients who have no other options. These are patients that have had at least two up to six or more approved approaches to battle their ovarian cancers, and those have all failed, and these patients are progressing and have basically no other options. In 2020- 2025, we achieved a number of goals.
We treated patients in the third and fourth dose cohort. Our trial is a dose escalating trial, which I'll show you in a moment, a dose escalation schedule. You know, each cohort is at a particular dose, and the successive cohort is at a higher dose once the previous cohort has demonstrated good safety or a good safety profile. We continue to observe positive safety and tolerability at all doses to date. As I noted, we've completed the third and fourth cohort last year. We're also seeing strong clinical efficacy signals that have not been seen on other CAR T solid tumor trials. Very, very exciting, which I'll show you in a moment.
In addition, we've received international and domestic approval of the generic name for the therapy, which is required eventually to get to commercialization. The therapy name is liraltagene autoleucel, or, in the way we refer to it, is lira-cel. In addition, very recently, just primarily because we have been able to demonstrate extremely good safety profiles for our dosage cohorts, we have received approval for going to higher doses to significantly more effectively attack the cancer. In fact, we received approval for dose levels that are higher than for any approved CAR T. Next slide. This is what the dosage plan looks like. We have completed the first four cohorts, 12 patients. In fact, we've done 13 patients to date.
We're beginning the fifth cohort shortly, which will include patients that are being given 10 to the seventh cells per kilogram of patient weight. In addition, we're gonna be utilizing a technique known as lymphodepletion, which is something that is required and used in the hematological CAR T approach, but it's not clear that it's necessary for solid tumors. We'll be testing that out in the next cohort. What that process does is it significantly suppresses the native immune system T cells, primarily, T cells and other immune cells, thus enabling the engineered T cells that we're delivering to the patient to graft much more effectively. It enables the engineered T cells to proliferate better and attack the cancer.
This approach, as I noted, has been used for the hematological conditions. Since there are no approved CAR T therapies to date, we don't know if this approach is gonna be necessary. The U.S. FDA as well as, of course, ourselves and our partner, Moffitt, is interested scientifically in determining if this approach provides better results than we've seen so far. Next slide. This is the reason why we do, what we do here. This is what's known as a swimmer's plot. For those of you who are not familiar, with this type of plot, let me take a minute to explain it. Each of these horizontal bars represents a single patient. And they look like, swimmers in each of their lane, and that's why colloquially it's called a swimmer's plot.
The x-axis is the duration in the number of months that a patient remains alive after getting our therapy. The y-axis is the dosage level, and you can see the four cohorts, three patients each, that we have dosed at the various noted levels. The vertical line, the red vertical line, is the median life expectancy for these patients. So as I noted, these are patients who have no other options. They've been essentially told to go home and get their affairs in order. Since this is the median, you would expect half the patients to survive past this line, but half the patients to have passed away before this line, roughly.
The patients who have the red triangles next to their bars are patients who have passed away at that month. The patients who remain alive in this study so far have the blue stars noted as noted. The important thing to note here is that nine of the 12 patients, 75%, all have lived longer than their median life expectancy. You'd expect some to live past the median life expectancy line. However, we have dramatically extended the lives of many of these patients. In fact, one patient survived for 28 months. She was expected to survive for about 12 weeks.
The four patients above near the top of this graph are continuing on, and we will monitor them and report their results in successive presentations that the company does. I also wanna note one thing. While we've extended the lives of many of these patients, we have not curatively treated them, which means we have not completely eliminated all of the tumor lesions that exist in these patients. In some cases, we've maintained stable disease for some time. In other cases, we've demonstrated significant tumor necrosis, meaning death of the cells within the tumor. However, we've not completely destroyed the tumor lesions, and as a result, all of these patients who have passed have passed due to eventual progression of their cancer.
We do believe this is yet to be proven that as we go to higher doses, we'll be able to destroy larger chunks of their tumor or perhaps, and our fingers are crossed on this, completely curatively treat these patients so that there's no diagnostic evidence of cancer in these patients. We anticipate completing at least two more cohorts going forward this year. Next slide. These are the goals for 2026. We want to understand the benefit or lack of benefit of lymphodepletion and whether it's necessary. We'll continue our dose escalation, at least through cohorts five and six. At the current time, we're only expected to do a total of nine more patients in cohorts five, six , and seven.
This trial should be ending after we've done the next three cohorts, depending on what kind of results we see. We'll, of course, continue monitoring the increase in patient survival of those patients who are still alive. We'll be presenting these results at scientific presentations, scientific conferences, and one should also expect that we will be receiving patents that we are prosecuting in not only the United States but also international regions, as we believe that this technology is gonna have tremendous value, and we want to make sure that we have proper intellectual property protection.
At this stage, we are going to begin in earnest speaking with pharma companies regarding commercialization of these products of this particular product because we have now demonstrated what we feel is significant overall survival for these patients, and ultimately, we hope we'll be able to demonstrate curative treatment as we go forward. Next slide. Now let me begin talking about the breast cancer vaccine and summarize that program. Next slide. As many of you may know, this vaccine uses a molecular mechanism that has never been utilized before. Designed to treat breast cancer in the neoadjuvant setting as well as the adjuvant setting. This is a therapeutic vaccine. We anticipate that it will be possible to treat patients before surgery in the neoadjuvant setting or after surgery in the adjuvant setting.
We also believe that this vaccine will be able to prevent recurrence. In the United States, there are roughly four million breast cancer patients who have survived breast cancer and are worried about the cancer coming back. We hope that this vaccine will be able to prevent those recurrences. Then finally, the big vision for this company for this product is to enable prophylactic treatment for patients who are concerned about getting breast cancer in the future. We call this primary prevention. The vaccine process is a three-shot regimen given every two weeks. Initially, the focus is on triple-negative breast cancer. Our trial has been focused on that, but this is expected to be effective for other subtypes as well.
In 2025, we completed phase I, the phase I trial at Cleveland Clinic and presented very positive and encouraging results at the San Antonio Breast Cancer Symposium in December of last year. San Antonio Breast Cancer Symposium is the largest cancer symposium annually focused on breast cancer. Our partners at Cleveland Clinic have submitted the Department of Defense report. As I noted earlier, the Department of Defense has funded this clinical trial. A preliminary FDA report has been submitted, although we're preparing a more detailed report to submit to the FDA. The IND has been transferred from our partner, Cleveland Clinic, to Anixa, so that now we can go forward in planning and beginning the phase II, which is what we are doing now.
We've also executed additional agreements to conduct further research at the Cleveland Clinic for this vaccine, as well as submitting grant applications, along with the Cleveland Clinic for additional funding for this vaccine work. Now, this is the summary of the groups of patients that were enrolled in the phase I trial, which we completed last year, last quarter of last year. We utilized three cohorts of patients. Cohort 1a was comprised of patients that had been diagnosed with triple-negative breast cancer, had gone through their treatment including surgery and adjuvant treatment, but are now worried about recurrence. Statistics show that 40% or more of these patients will recur within five years. We wanted to see how the vaccine would work in these patients.
The second group of patients, cohort 1c , are patients who've never had breast cancer but carry the genetic mutations that are known to predispose them to getting breast cancer in the future. These are patients that have chosen to have prophylactic mastectomies. They've chosen to have their breast surgically removed, even though at that time they're perfectly healthy to prevent or lower the risk of getting breast cancer in the future. In these cases, we have vaccinated these women before their surgeries. After their surgery, we have a tremendous amount of purportedly healthy tissue to study. We're in the process of doing that, those studies right now. The third cohort, 1 C, comprise of patients who have completed their triple-negative breast cancer treatment, including surgery and adjuvant treatment, but still have residual disease.
Meaning these patients still have cancer micro tumors in their body, but those are not able to be surgically removed. These patients continue to get additional adjuvant treatment, including a cancer drug name known as KEYTRUDA. KEYTRUDA has been approved for this particular purpose, but it only works in a modest fraction of these patients. We wanted to see if adding the vaccine to KEYTRUDA could potentially be synergistic and enable more curative treatments for these patients. In the phase I trial, the goal was to evaluate whether our vaccine, along with KEYTRUDA, would increase the side effect profile. KEYTRUDA already has a side effect profile which makes it intolerable for many patients.
If we added another agent like our vaccine, and that created even more difficult side effects, then it would not be possible to utilize that combination. Our goal here was to verify that the side effect profile did not change dramatically, and we did verify that. As a result, we feel that a combination of Keytruda and the vaccine can be used in a therapeutic modality in our phase II study. Next slide. This is just a summary of the phase I study. Many of you may have seen this slide before. We had 35 patients that were enrolled in this trial. Twenty-six of them were cohort 1a, which are the triple-negative breast cancer patients that have completed their journey.
Four patients were in the cohort 1b . These are patients who are having a prophylactic mastectomy, and five patients were patients with residual disease that were taking KEYTRUDA, cohort 1c. The key findings were that we achieved all of our primary goals. Maximum tolerated dose was reached, which is a dose we may use as we go forward in phase II. The most important conclusion was that there were no safety concerns because if this product is eventually approved for long-term prophylactic use, it could be given to very extremely large numbers of women, and safety is an important factor there. We saw no safety concerns.
The only issues that were seen were perhaps mild fevers for a short period of time within hours. The other side effect that was occasionally seen was irritation at the sites of injection. The right-hand portion of the slide depicts graphs of immune response. The top two frames are types of T cells that are responding to the vaccine. The bottom frame is an antibody response, which is a B cell response. Basically what this tells us is that a large number of women, about three-fourths of these women, were having strong immune responses, which means the vaccine was teaching their immune systems to target the protein that is found on the cancer cells. The other responses were more.
The other responses were more modest, but we believe that even a modest response could potentially be successful in targeting and/or preventing breast cancer. The other conclusion that I noted earlier in the previous slide is that our KEYTRUDA combination with the vaccine exhibited no additional adverse side effects. Enabling combination use. Phase I is completed. We've submitted the initial report to the FDA, and we'll be submitting another report. We've transferred the IND, so we're beginning to plan the phase II. Next slide. The phase II we anticipate will be in the neoadjuvant setting. Typically, when a woman is diagnosed with breast cancer, before her surgery, she's given therapy, chemotherapy and/or immunotherapy. Typically, the immunotherapy is KEYTRUDA. In this phase II study, we anticipate splitting the participants into two groups.
The placebo group will get the standard of care, and the vaccine group will get standard of care plus the vaccine, and we'll evaluate how the two groups do to evaluate whether the vaccine is having a synergistic effect alongside the KEYTRUDA. Next slide. Our goals for this year for the vaccine trial is to begin manufacturing of a larger amount of the vaccine, filled and finished, with a more extensive and comprehensive quality control than in the phase I material. We anticipate submitting a phase FDA report, having FDA meetings to help guide us in designing the phase II trial, which with a lot more detail than we have at the current time. We'll eventually be selecting sites.
As many of you may know, the phase I trial was done at a single site at our partner at Cleveland Clinic. Phase II will commence at not only Cleveland Clinic, but also other cancer centers. We'll be publishing the data that we have so far. We'll be doing additional presentations as well as you know, intellectual property prosecution and grants. We already have begun pharma partner discussions, and we'll continue those going forward for commercialization. Next slide. This is just the last slide talking about some of our preclinical programs. The furthest advanced is our ovarian cancer vaccine program, which is being developed alongside Cleveland Clinic and the National Cancer Institute with funding from the National Cancer Institute.
We are performing some discovery programs in other types of cancer, and we'll be talking about some of those in the coming months. Next slide. Let me just finish with the goals that I've already stated for each of our programs as well as the preclinical program. We have a busy year expected going forward. We anticipate a lot of catalytic achievements going forward. We believe that this will enable us to seriously begin pharmaceutical partner discussions for completion of the trials as well as for commercialization of our technologies. That's it. Next slide. Just conclusion. We're done. Do we go back to Drew? Drew?
Okay. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
Actually, Drew. Oh.
Go ahead. Sorry.
We're gonna have some Q&A.
Oh, okay. Go ahead. Apologies. Thank you.
There's a question. This is Mike again. I'll run the questions here for Amit. There's a question here, and actually, this question, we get a lot of emails about this as well. And it's really about the upcoming phase II clinical trial for our breast cancer vaccine. People have a lot of questions and ask us frequently about how they can participate in that trial and, you know, when and where the different clinical sites would be. Amit, would you like to expand on that a little bit?
Yeah. We will have multiple clinical sites in the United States in different regions. We've not identified what those sites are yet. As we sign on additional sites, we will note them with press announcements.
Stay tuned to our website to understand the additional sites that we're bringing on. We will have additional sites. We anticipate anywhere from 15-20 sites.
Thanks, Amit. Another question is, do you anticipate challenges enrolling at the higher doses in the CAR T trial given the added lymphodepletion for these sick patients? Are you observing a dose-dependent response in survival or tumor burden reduction for ovarian cancer?
Two parts. We do not anticipate enrollment challenges at the higher dose levels. It's not uncommon for patients at this stage of their cancer to not even want to participate in clinical trials.
Those who do wanna participate in clinical trials certainly are going to participate independent of whether lymphodepletion is being used or not. Because at this point, at the point we get them, they've only got weeks to live. If they want to participate and try and fight, then they will participate in the trial. We don't anticipate that being a limiting factor. You know, as far as dose-dependent response, to a modest degree you can say that we are, but it's not absolutely clear. We believe that we will have dose-dependent response, primarily because we feel that a higher dose is going to result in a larger, you know, attack on the tumor. We'll have to see.
We don't have enough patients to really make conclusive statements about that.
That question was from Yi Chen, a research analyst at H.C. Wainwright, and he actually had a follow-up question on the breast cancer vaccine. He's asking: How do you interpret the 74% immune response, and how does it compare with prior cancer vaccines?
The 74% immune response, we think we're pleased with, but basically that response was based on an arbitrary, an indication of what we felt was going to be successful in preventing breast cancer. That being said, as you know, cancer starts out as one cell, then turns into two, four, eight, 16, and continues multiplying until it becomes a large tumor, multibillion cell mass that can be seen in a mammogram, for example.
We feel that if we have properly trained the immune system to destroy this, the cancer cells, even at an early stage, especially at an early stage I should say, when the cancer is comprised of four cells or eight cells or 16 cells, we feel that a modest immune response will be able to destroy those cells and not enable the cancer to become a large tumor. As far as the immune response, historically, we have seen immune responses with other cancer vaccines, but for reasons that I won't discuss today, we feel other cancer vaccines utilize a flawed mechanism scientifically, a molecular mechanism that we think is somewhat flawed. Our immune response, we feel is significantly superior to what has been seen with prior cancer vaccines.
Great. Thanks, Yi, for those questions. We have another question from Boris Tolkachiev. He's a research analyst that covers us from Freedom Capital. His question is about our ovarian cancer program. The question is: as the phase one trial in ovarian cancer progresses successfully, what efficacy signals will you view as key indicators for advancing this asset to the next stage of development? And also, could you clarify why the CAR T doses in the cohorts with lymphodepletion are actually higher than in the cohorts without lymphodepletion?
A two-part question. You know, so we do analysis of patients. We do blood work. We do scans of their patients, CT scans to evaluate what we can see about their cancer lesions. We'll be doing cytokine analysis of these patients. We'll be doing flow cytometry analysis of these patients to look at persistence and other factors of the CAR T cells. Ultimately the goal here is overall survival. Regardless of what you see on these other biomarkers and measurements, the real question is, are you extending the lives of these patients? That's the reason why that's the only slide I showed you during the presentation, because that's really what matters. Can you make patients live longer?
Can you improve their quality of life? We've demonstrated that, at least at this early- stage 12- patients in study, we've been able to do that for a number of patients. Overall survival is the key attribute. As you may know, the U.S. FDA, even though there's been some turmoil with the leadership level recently, overall survival is the primary goal for these types of therapies. If you can demonstrate overall survival, it really doesn't care what other biomarkers are saying. If the patients are living longer and with good quality of life, that's really what matters. The second part, could you clarify why the CAR T doses, dosages in the successive cohorts with lymphodepletion are higher than in the cohorts without?
Because we feel that we've got good safety data early on, and lymphodepletion will certainly provide a little bit more difficulty from a safety standpoint. We feel we wanna go to higher dosages because we're already seeing some indicators of efficacy at the lower dosages, and we feel that at higher dosages with the boost of lymphodepletion might push this into curative treatment for ovarian cancer.
Great. Thanks, Boris, for those questions. Another question about our ovarian cancer therapy. This question is really about, you know, what the thinking is, on higher dosing versus more frequent lower dosing.
Well, thank you for that question. I didn't mention one other aspect of our clinical trial protocol. We did receive some time ago from the U.S. FDA the permission to provide a second dose to patients for whom we felt a second dose was beneficial. We did give a second dose to that one patient that had lived for 28 months because she had received a very low dose initially. We believe that heavier dosing will be sufficient to prevent, or I should say, to curatively treat ovarian cancer. That would be much better than frequent dosing for not only the patient, but also for the healthcare system with regard to cost and logistics and so forth.
We don't know the answer to this question yet, but we believe that the heavy dosing is going to be successful, and we hope that we don't require frequent dosing of patients.
Great. There's one other question. Actually, it's a bit of a housekeeping question just to clarify, and I've had a couple questions offline about this. This annual meeting, this virtual meeting is audio only. There is no video. So if anybody thinks they're missing the video, there isn't a video to miss. This has been audio only. So just so you know, you're getting the whole experience right here.
Although the slides, the only.
Yes, the slides are.
Yeah.
Exactly. Not video, but there is a visual component with the slides. That is it. I see no additional questions. We're going through one last time here, but no, it looks like we've addressed all the questions that came in. Amit, any concluding remarks?
Yeah. Thank you for attending. I'm sure many people will also listen to this and watch this presentation later on the recorded version. If you have additional questions, please feel free to call us and we'll do our best to address those questions. Drew, we're all wrapped up.
Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.